NIKO 8200

GUDID 00853512006974

THERMAL RELECTORS - LARGE

NIKOMED USA

Infant heat shield

• Primary Device ID: 00853512006974
• NIH Device Record Key: 4d72347d-db89-4c4e-8180-7d5434e81498
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIKO
• Version Model Number: 8200
• Catalog Number: 8200
• Company DUNS: 073648341
• Company Name: NIKOMED USA
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)355-6456
• Email: info@nikomedusa.com
• Phone: +1(800)355-6456
• Email: info@nikomedusa.com
• Phone: +1(800)355-6456
• Email: info@nikomedusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853512006974 [Unit of Use]
GS1	10853512006971 [Primary]
GS1	20853512006978 [Package]; Contains: 10853512006971; Package: Box [5 Units]; In Commercial Distribution

FDA Product Code

• KGX: Tape And Bandage, Adhesive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-17
• Device Publish Date: 2025-12-09

On-Brand Devices [NIKO]

• 00853512006981: THERMAL REFLECTORS - SMALL
• 00853512006974: THERMAL RELECTORS - LARGE